KCT0008856
Recruiting
未知
Effects of a ATNC MDD-V1 (TMS with cognitive training), for the Treatment of Mild Alzheimer Disease: a Randomized, Double-blinded, Placebo-controlled Study
AT&C0 sites158 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- AT&C
- Enrollment
- 158
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Patients who started drug treatment with an acetylcholinesterase inhibitor at least 2 months before participating in the clinical trial and can participate in the clinical trial without changing the dose during the trial period.
- •2\.Male or female age 60\-85 years.
- •3\.Patients diagnosed with mild stage of Alzheimer's Disease, according to the NIA\-AA (2011\) diagnosis.
- •4\.MMSE score 21 to 26\.
- •5\.CDR 1 or GDS 3\.
- •6\.Patients with a positive amyloid PET\-CT.
- •7\.Patients who are judged physically capable of clinical trials based on medical records and examinations.
- •8\.Patient whose legal representative agrees to participate in a clinical trial and who can visit for the next observation with a guardian.
- •9\.Patients who agreed to participate in all 24\-week clinical trials.
- •10\.Patients with normal ability to see and hear letters.
Exclusion Criteria
- •1\.Patients with a central nervous system disease that can affect cognitive function and is likely to be another cause of cognitive decline, or a type of dementia other than Alzheimer's, is suspected.
- •2\.Patients who have been unconscious due to brain surgery or concussion, or who have signs or symptoms of cranial pressure elevation on neurologic examination.
- •3\.History of Epileptic Seizures or Epilepsy.
- •4\.Patients with a history of drug abuse, including alcohol, in the past 5 years from the time of screening.
- •5\.Patients with schizophrenia, schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, panic, post\-traumatic stress, severe anxiety, mental retardation, DSM\-V disorder.
- •6\.Patients with abnormal vitamin B12, folic acid deficiency, or thyroid stimulating hormone (TSH) test results that were considered by the investigator to affect or are caused by the severity of dementia.
- •7\.Patients with metal implants in the head, (i.e. cochlear implants, implanted brain stimulators and neurostimulators, aneurysm clips) with the exception of metal implants.
- •8\.Cardiac pacemakers.
- •9\.Implanted medication pumps.
- •10\.Intracardiac lines.
Outcomes
Primary Outcomes
Not specified
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